How can DHA algae oil and protein be combined with other nutrients when applying for filing? Toxicology tests to be required

On June 14, 2023, the State Administration for Market Regulation released four official documents:

• Health Food Raw Materials Directory of Nutrient Supplement (2023 Edition);
• Health Function Directory of Allowing Nutrition Supplement Claims (2023 Edition);
• Health Food Raw Materials Directory – Soybean Isolated Protein; and
• Health Food Raw Materials Directory – Whey Protein.

On July 5, 2023, the supporting technical specifications and interpretation documents (draft for soliciting opinions) of the above-mentioned documents were released for public opinion. Comments are welcomed before August 4, 2023.

Newly added filing functional health food raw materials – protein

• Product dosage form: powder
• Available raw materials and excipients:

Notes: The filers shall provide product safety evaluation tests for compatible nutrients in accordance with the latest edition of the Technical Guidelines for Toxicological Testing and Evaluation of Health Food and Its Raw Materials, and the types and quantities of nutrients used shall be listed in the health food raw material directory. The available health function is limited to "enhance immunity", and the precautions should also be compliant with the requirements for the filing of nutrient supplements. Additionally, the applicant is also required to provide a commitment statement outlining their responsibility for the safety, efficacy, and quality controllability of the products.

Newly added filing nutrient supplement raw material – DHA algal oil

• Product dosage form: available dosage forms for registration (tablet, hard capsule, soft capsule, oral solution, granule, gel candy (gummy), and powder)
• Available raw materials and excipients
• The raw materials must comply with the Health Food Raw Materials Directory of Nutrient Supplements, and the excipients must be compliant with the Available Excipients for Health Food Filing and Their Usage Rules.

Notes: It is recommended to use DHA algal oil as a single ingredient for product filing. If it is necessary to combine DHA with other nutrients included in the Health Food Raw Materials Directory of Nutrient Supplement, the applicant must provide product toxicological evaluation test data and development & research materials in accordance with the Guideline on the Safety Toxicological Inspection and Evaluation of Health Food and Its Raw Materials (2020 Edition), as well as a commitment statement responsible for product safety, efficacy, and quality controllability.

CIRS Comments

1) Proteins listed in the raw material catalog with specific health functions do not fall into the category of nutrients such as supplementing vitamins and minerals. According to the Food Safety Law and the Health Food Registration and Filing Regulation,  filing of the above-mentioned substances is exclusively for domestic products and does not cover first-imported health foods. DHA algal oil, which can supplement n-3 Polyunsaturated fatty acid, and falls under the category of supplementing nutrients. The filing is applicable to both domestic and imported products.

2) Companies need to conduct toxicological tests when DHA algae oil and protein are combined with other nutrients. Acute oral toxicity tests, genotoxicity test battery, and a 28-day oral toxicity test should typically be performed on health food, according to the Guidelines on the Safety Toxicological Inspection and Evaluation of Health Food and Its Raw Materials (2020 Edition).

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